The Acting FDA chief, Janet Woodcock, recently announced that Patrizia Cavazzoni will take her former role as director of the FDA’s drug center. Biden’s picks for the CMS administrator and HHS deputy secretary, Chiquita Brooks-Lasure and Andrea Palm were both recently questioned by the Senate Finance Committee for their confirmation hearing. The hearings included questions regarding the state of the 340B drug discount program, but there was no major opposition from Senate Republicans. To read the full article, click here.
The Ensuring Innovation Act (S. 415) and Advancing Education on Biosimilars Act of 2021 (S. 164) were both passed in the Senate last month. The Ensuring Innovation Act will aim to prevent awarding five years of exclusivity to drugs that are not significantly different to existing drugs. The Advancing Education on Biosimilars Act of 2021 will create a website with educational material on the FDA’s standards for reviewing biologics and biosimilars. To review the article, click here.
The report evaluates the trends in investments into pharmaceutical research and development and the introduction of new drugs over the past decade. Using data provided by PhRMA, CBO highlighted key factors that manufacturers evaluate before investing into a new drug, including the expected revenue and policies that may affect the supply and demand of the drug. The report also discusses the role of federal funding in creating innovation drugs. NIH research, which has totaled over $700 billion in federal funding over the past two decades, has been involved in every new FDA-approved drug from 2010-2016. To read the full report, click here.
In 2010, Endo International offered Impax Laboratories $112 million for Impax to delay the release of their generic painkiller for an additional three years. The FTC claimed that over the3 years where US consumers were forced to choose the brand name drug, they spent an extra $3.5 billion annually. To read the entire article, click here.
The campaign focuses on Washington, DC and ten key states through digital advertising and grassroots mobilization. The campaign sites findings from a survey done earlier this year that found 87% of American voters think it is important for policymakers to keep 2020 campaign promises on lowering prescription drug costs. To read the press release, click here.
Dozens of patient groups have come out in protest of Cigna’s new incentive. Patient groups are arguing that incentivizing patients to switch drugs without medical advice (that may not even have the same mechanism of action) is unethical. To read about Cigna’s new incentive, click here.
Sean Dickson spoke with Inside Health Policy on the impact of Part D plans favoring expensive brand drugs. Dickson explained that the expensive branded version of hepatitis C drugs allows Part D plans to shift more costs onto beneficiaries, as cost sharing is based on the list price. To read the full article, click here.
Stacie Dusetzina spoke with Bloomberg Law on drug pricing reforms vital to cost inequities. On allowing the government to negotiate drug prices, Dusetzina said that it is unclear if Medicare negotiation would result in cost disparities based on insurance. She continued that just because the bill will provide people in Medicare and Medicaid with better discounts, it does not necessarily mean those with private plans will have worse outcomes. To read the full article, click here.
Richard Frank coauthored an article on improving competition among generic drugs in the Health Affairs blog. The article focuses on the Generic Drug User Fee Act (GDUFA), as it must be reauthorized in 2022. While the GDUFA has been successful in funding the FDA to expedite generic drug approvals, the researchers argue that it has not done enough to encourage competition within the generic drug markets. To read the full article, click here.